News on non-animal methods
MARCH 30 - APRIL 03, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. UK: MHRA published guidance on its approach to medicines developed using non-animal methods
The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines, medical devices and blood components for transfusion in the UK, rigorously using science and data to inform its decisions, enable medical innovation and make sure that medicines and healthcare products available in the UK are safe and effective.
MHRA just published guidance on its approach to medicines developed using non-animal methods. By offering early review of non‑animal data and clarifying how it will be assessed, the UK’s medicines regulator aims to give developers more confidence when making marketing applications based on evidence generated without animal testing. “A clearer regulatory route for medicines developed without animal testing will help accelerate the transition to modern, predictive science and support the Government’s strategy to reduce and ultimately replace animals in research.” says Julian Beach, Interim Executive Director Healthcare Quality and Access.
2. India: Non-animal testing could cut drug costs by up to 90%
India’s pharmaceutical industry is beginning to see a sharp shift in how drugs are tested, as science-led non-animal methods (NAMs) move from theory to real-world use. A new multi-stakeholder report says these approaches can cut drug development timelines by more than half and reduce costs by as much as 70 – 90 per cent, while still meeting global regulatory standards.
Indian companies are already starting to act on this shift. At Dr Reddy’s Laboratories (DRL), NAMs are being integrated into early toxicology and mechanistic studies, while large datasets from existing studies are being combined to build India-specific models. “We are beginning to see the benefits firsthand,” said Deepak Sapra, chief executive officer (CEO), API and services, Dr Reddy’s. “Other companies such as Biocon and Sun Pharma have also shown early interest, especially where NAMs clearly reduce timelines or lower regulatory risk.”
3. New method identifies hazardous substances in cosmetics and food
Substances capable of mutating human genetic material – altering and permanently damaging it – are present in many everyday products. Researchers at Justus Liebig University Giessen (JLU) have, for the first time, detected mutagens and concurrently cytotoxic substances in food, meat, smoke flavourings, personal care products, and even water.
To achieve this, they developed a novel screening procedure enabling the determination of the mutagenicity of individual substances within complex mixtures. “In contrast to previously used in vitro tests, we can now reliably, quickly, and cost-effectively test complex samples. Through planar separation and bioassay detection on the same adsorbent surface, we no longer have limitations – such as those relating to solubility or interfering signals,” explains Professor Morlock, Chair of Food Sciences at JLU.
TOOLS, PLATFORMS, CALLS
4. Human Cancer Models Initiative: 2D and 3D patient-derived models
ATCC now provides the Human Cancer Models Initiative (HCMI) models, which include both common as well as rare and understudied examples of cancer from numerous tissues. These HCMI models are valuable tools to study cancer, identify and target novel therapies, and facilitate translational cancer research. To enhance their clinical relevance, the sequence data and patient clinical information for each model is available to the research community.
5. Nature Collection: Organoid models for infectious diseases
Organoid models recapitulate many characteristics of in vivo disease and provide new insights into the diverse human host – microbe interactions. Pluripotent and tissue stem cell – derived organoids possess a high degree of similarity to human physiological states and have strong self-organizing capabilities, and have demonstrated potential as invaluable tools for the development of novel diagnostic strategies and targeted therapies.
With a new cross-journal Collection, the editors of Communications Biology and Nature Communications welcome the submission of primary research Articles focusing on recent advances of stem cell-based organoid models for studying infectious diseases, and novel insights in the disease mechanisms of human infections with the support of stem cell-based organoid systems.
6. Drug Discovery News: Key resources
Here’s a list of key resources on NAMs provided by Drug Discovery News: infographics, whitepapers, ebooks, technology guides, etc.
- Bridging the gap in ALS research with human cell models – Whitepaper
- Powering kidney disease research with integrated clinicogenomic data – Infographic
- The future of 3D cell analysis: from isolation to insight – Ebook
- Assessing liver safety with microphysiological systems – Technology guide
- The journey of 3D bioprinting – Milestone
- Charting a cellular treasure map with spatial transcriptomics – Infographic
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INDUSTRY, BIOTECH & PARTNERSHIPS
7. Curi Bio and Battelle: A strategic partnership to accelerate NAMs adoption in neuromuscular pharmacology
Curi Bio, a world leader in human-relevant 3D tissue technology, and Battelle, the world’s largest independent nonprofit research and development organization, announced a strategic partnership to commercialize next-generation Neuromuscular Junction (NMJ) assay technology.
This collaboration combines Curi Bio’s innovative microphysiological systems with Battelle’s extensive GLP-ready infrastructure to offer a transformative, human-relevant alternative to traditional pharmacology methodologies.
8. Xaira Therapeutics launches its first virtual cell model
Xaira Therapeutics has announced X‑Cell, the company’s first virtual cell model. It is a 4.9‑billion-parameter diffusion language model designed to predict how cells respond to genetic perturbations, including in biological contexts not seen during training. X‑Cell is trained on X‑Atlas/Pisces, which Xaira says is the largest and most context-diverse genome-wide CRISPRi Perturb-seq dataset ever reported.
Xaira emerged in April 2024 with over $1 billion in funding, led by CEO Marc Tessier-Lavigne and co-founded by Nobel laureate David Baker. Xaira’s roadmap calls for expanding X‑Atlas into primary cells, iPSC-derived cell types, organoids, and in vivo perturbations. The downstream applications of target identification, mechanism of action, patient stratification, toxicity prediction — all remain prospective at this stage, but the data-and-model foundation is now in place for testing them.
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. AI agents in drug discovery: Applications and case studies
AI agents are emerging as transformative tools in drug discovery, with the ability to autonomously reason, act and learn through complicated research workflows. Building on large language models and specialized tools, these systems can integrate biomedical data, execute tasks, conduct experiments and iteratively refine hypotheses.
A new article provides a conceptual overview of agentic AI architectures and illustrates their applications across key stages of drug discovery, including literature synthesis, automated protocol generation, toxicity prediction, small-molecule synthesis, drug repurposing and end-to-end decision-making. Early implementations demonstrate substantial gains in speed, reproducibility and scalability. The authors discuss the challenges related to data heterogeneity, system reliability, privacy, benchmarking and outline future directions toward technology in support of science and translation.
Read the article in Drug Discovery Today
10. NAMs for assessing potential proarrhythmic risk and cardiovascular safety
Cardiotoxicity — especially arrhythmia — has long been a major reason drug candidates fail during development, making cardiac safety testing critical for regulatory approval and patient protection. Current assessments follow ICH S7B/E14 guidelines, using in vitro assays and in vivo approaches to estimate the risk of dangerous heart rhythm events. While these methods help prevent unsafe drugs from reaching the market, they rely on indirect markers with limited predictive accuracy and can lead to the rejection of potentially safe compounds.
Emerging approaches — such as advanced cell culture systems, organ-on-chip technologies, and computational methods including AI — offer more human-relevant and potentially more accurate alternatives. These new methodologies could reshape regulatory practices, improving risk prediction while reducing reliance on animal testing.
11. Bone organoids: A novel tool for modeling and managing skeletal disorders in diabetes
Diabetes has a significant but not fully understood impact on bone health, leading to increased fragility that current in vitro and animal models fail to accurately replicate. Although organoid technologies have rapidly advanced as tools for studying human biology and disease, bone organoids remain relatively underdeveloped compared to those for other tissues, limiting progress in this area.
Bone organoids can be created through self-assembling cells or scaffold-based methods, both of which can mimic essential features of real bone, such as its cellular complexity and structural organization. A new review highlights recent progress in bone organoid development and uses diabetic bone disease as a key example to show how improved, next-generation models could better capture disease mechanisms and support the development of more effective treatments.
Read the review in Advanced Science
WORTH (RE)SHARING
Donor variability in iPSC models is data, not noise – By Sam Lloyd-Burton
OOC: Microfluidic technology enables culture of organoids with enhanced tissue function and potential for disease modeling – Review article
The organ-on-a-chip is not cheaper. It is differently expensive – by Stefano Gaburro
Report of the first Ombion Scientific Conference
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
BTS – SETAC UK Workshop – April, 29 from 1:30 – 6:00 pm GMT, VOCO St John’s Hotel (In person) – You can complete this survey to help inform discussions on the workshop charge
The Global Education Hub for animal-free innovation: On a mission to make education on non-animal research the norm worldwide – April, 14 7:00 pm CET (Online)
